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Spatiotemporal tSCS in Spinal Cord Injury

Spatiotemporal Control of Transcutaneous Spinal Cord Stimulation for Motor Function in SCI

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07397559
Enrollment
48
Registered
2026-02-09
Start date
2026-01-19
Completion date
2030-08-31
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries (SCI)

Keywords

spinal cord injury, transcutaneous spinal cord stimulation, rehabilitation

Brief summary

Spinal cord injury leads to long-lasting impairment, and currently, there is no cure for paralysis. Although transcutaneous spinal cord stimulation has shown promising results in recovering lost movements, its poor selectivity in muscle recruitment compared to invasive approaches limits the type of rehabilitation exercises that can be practiced. This project studies how spatial, frequency, and amplitude control of stimulation can be used to selectively target different neural pathways and muscle groups.

Detailed description

Spinal cord injury (SCI) is a life-altering event that leads to long-lasting motor impairment. Currently, there is no cure for paralysis. Transcutaneous spinal cord stimulation (tSCS) combined with exercise training can restore posture control, voluntary walking, and arm/hand function in people with SCI. However, its low selectivity in activating specific muscles compared to invasive approaches limits the rehabilitation exercises that can be practiced and help with recovery. This project will generate evidence-based knowledge of the neural mechanisms underlying spatial, frequency, and amplitude control of tSCS in generating different types of leg movements. Participants with SCI will perform leg movements using different stimulation parameter configurations in non-invasive tSCS. We will quantify changes in muscle recruitment, torque generation, and pain enabled by the different stimulation parameters. A clear understanding of the mechanisms by which these different parameters in non-invasive tSCS can be used to selectively target different muscle groups will promote the development of personalized therapies that directly target only those muscles that need assistance while respecting individuals' residual motor function.

Interventions

Participants complete motor tasks and outcome assessments with no spinal cord stimulation applied.

DEVICEConventional tSCS

Non-invasive transcutaneous spinal cord stimulation (tSCS) is delivered at 30 Hz using a single cathode electrode targeting the lumbar spinal cord to reinforce leg motor output during study tasks

DEVICESpatiotemporal tSCS

Stimulation parameters, including electrode location, stimulation frequency, and stimulation amplitude, are systematically varied to reinforce leg motor output during study tasks

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Age between 16 and 65 years. 2. Have a spinal cord injury (neurological level C3-T12) that occurred ≥1 year (chronic stage) prior to enrollment. 3. American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification C or D 4. Able to voluntarily contract (motor score ≥ 1) at least two leg muscles (visual or palpable contraction). 5. Use of prescription medication(s) for control of spasticity has not changed in the last 2 weeks 6. Able to provide consent 7. Ability to follow multiple instructions and communicate pain or discomfort

Exclusion criteria

1. Progressive spinal lesions, including degenerative disorders of the spinal cord 2. Pregnant, planning to become pregnant, or currently breastfeeding 3. History of cardiopulmonary disease or cardiac symptoms 4. Implanted stimulators of any type (baclofen pump, epidural spinal stimulator, cardiac defibrillator, pace-maker, etc.) 5. Presence of orthopedic conditions that would negatively affect participation in leg exercise 6. History of autonomic dysreflexia that is severe, unstable, and/or uncontrolled 7. Unstable or significant medical conditions that can interfere with exercise or neurophysiological evaluations, such as severe neuropathic pain, depression, mood disorders, or other cognitive disorders 8. Spasms that limit the ability to participate in leg exercise activity 9. Breakdown in skin area that will be in contact with electrodes

Design outcomes

Primary

MeasureTime frameDescription
Changes in Torque30 minutesThe primary outcome is a measure of changes in voluntary torque production (Nm)

Secondary

MeasureTime frameDescription
Muscle activation30 minutesMuscle activation will be measured through electromyography as the peak-to-peak of the evoked responses (mV)
Pain/Nociception30 minutesPain will be evaluated using the Nociception Level (NOL) index during the different stimulation conditions. (Range: 0-100, 0 = no detectable nociceptive response, 100 = extreme nociceptive response)

Countries

United States

Contacts

CONTACTIsmael Seáñez, PhD
ismaelseanez@wustl.edu314-935-7665
CONTACTCarolyn Atkinson, BS
a.carolyn@wustl.edu314-935-4530

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026